| Name | BBP 398 |
| Synonyms | BBP398 BBP-398 IACS15509 IACS 15509 IACS-155509 |
| Use | SHP2 Inhibitor-New Drug, Possible for Advanced Non-small Cell Lung Cancer |
Sponsor:
Navire Pharma Inc., a BridgeBio company
Collaborator:
Bristol-Myers Squibb
Information provided by (Responsible Party):
Navire Pharma Inc., a BridgeBio company
This is a phase 1 study of SHP2 inhibitor BBP-398 in combination with PD-1 antibody nivolumab in patients with KRAS mutant NSCLC. The study consisted of two parts: phase 1a dose escalation and phase 1b dose expansion.
disease or disease intervention/treatment stage
Non-small cell lung cancer
Solid tumor
Drugs: BBP-398 and nivolumab
Stage 1
Detailed description:
The main purpose of phase 1a dose escalation is to evaluate the safety, tolerability and RP2D of BBP-398 (a SHP2 inhibitor) combined with nivolumab in patients with advanced NSCLC with KRAS mutation.
The main purpose of phase 1b dose expansion is to evaluate the antitumor activity of BBP-398, as defined by ORR (per investigator) in RECIST v1.1, when it is used in combination with nivolumab in patients with advanced non-small cell lung cancer with KRAS mutation and does not meet the standard of care.
Research design
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Type of study: intervention (clinical trial)
Estimated number of applicants: 45
Allocation: non-random
Intervention model: sequential allocation
Mask: None (open label)
Main use: Other
Official title: Phase 1 study of SHP2 inhibitor BBP-398 (formerly known as IACS-15509) in combination with programmed death receptor 1 blocking antibody Nivolumab in patients with advanced non-small cell lung cancer with KRAS mutation
Estimated study start date: May 2022
Estimated preliminary completion date: July 2024
Estimated completion date of the study: January 2025
experimental group and control group
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ARM intervention/therapy
Experiment: dose escalation level 1
Grade 1 oral capsule combined with nivolumab
Drugs: BBP-398 and nivolumab
BBP-398 oral once daily (QD); intravenous nivolumab every 4 weeks (4 weeks)
Experiment: dose escalation level 2
Grade 2 oral capsule combined with nivolumab
Drugs: BBP-398 and nivolumab
BBP-398 oral once daily (QD); intravenous nivolumab every 4 weeks (4 weeks)
Experiment: dose escalation level 3
Grade 3 oral capsule combined with nivolumab
Drugs: BBP-398 and nivolumab
BBP-398 oral once daily (QD); intravenous nivolumab every 4 weeks (4 weeks)
Experiment: Dose expansion
RP2D defines dose. Oral capsules combined with nivolumab
Drugs: BBP-398 and nivolumab
BBP-398 oral once daily (QD); intravenous nivolumab every 4 weeks (4 weeks)
suitable age for learning: 18 years and above (adults, elderly)
Gender eligible for the study: all
Accept healthy volunteers: No
Standard
Key selection criteria:
Patients must have histologically documented, locally advanced, unresectable or metastatic NSCLC within 1 year prior to screening, and have KRAS mutations documented.
The patient must have a measurable disease as prescribed by RECIST v1.1.
After starting study therapy, the patient's minimum life expectancy must be greater than 12 weeks.
Patients must have progression or disease recurrence on or after at least one previous systemic therapy line, which must include platinum-based dual chemotherapy and anti-PD-(L)1 therapy.
Patients must have experienced progressive or recurrent disease during treatment or within 90 days after stopping anti-PD-(L)1 therapy.
Patients must have Eastern Cooperative Oncology Group (ECOG) Performance Status (PS)0-1.
Patients must have adequate organ function.
Key exclusion criteria:
Patients who participated in interventional clinical studies in the past 4 weeks.
Patients who received radiotherapy or proton therapy within 1 week after the start of study therapy received limited radiotherapy to relieve symptoms within 4 weeks after the end of study therapy, or received radiotherapy to more than 30% of bone marrow, or received too wide radiotherapy.
Patients with known central nervous system (CNS) tumors or active CNS metastases.
Patients who experienced progressive disease (PD) within the first 120 days of starting treatment with anti-PD-(L)1 drugs (e. g., primary refractory).
Patients with a history of allogeneic bone marrow transplantation.
Patients with known or suspected autoimmune disease were selected.
Patients requiring systemic therapy with corticosteroids (> amp; gt; 10 mg prednisone equivalent) or other immunosuppressants within 14 days of study initiation.
Patients who received any live vaccine/attenuated vaccine within 30 days after the first study treatment.